MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2012-12-06 for RUSCH RR MAGIL/CUFFED ET TUBE, 3.0MM 102000030 manufactured by Willy Rusch Gmbh.
[2985981]
The event is reported as: the customer alleges that et tube has a defect and it seems to be leaky. Patient is fine. No report of a patient injury.
Patient Sequence No: 1, Text Type: D, B5
[10332498]
The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610520-2012-00018 |
| MDR Report Key | 2864480 |
| Report Source | 01,06,07 |
| Date Received | 2012-12-06 |
| Date of Report | 2012-11-21 |
| Date of Event | 2012-11-01 |
| Date Mfgr Received | 2012-11-21 |
| Date Added to Maude | 2013-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN, CLINICAL SPEC |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | WILLY RUSCH GMBH |
| Manufacturer Street | WILLY RUSCH-STR. 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH RR MAGIL/CUFFED ET TUBE, 3.0MM |
| Generic Name | RED RUBBER ENDOTRACHEAL TUBE |
| Product Code | BYW |
| Date Received | 2012-12-06 |
| Catalog Number | 102000030 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLY RUSCH GMBH |
| Manufacturer Address | KERNEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-06 |